Senior Technical Steward (d/f/m) / Višji ekspert procesnih tehnologij (d/ž/m)
Posted: 3 days ago
Job Description
Job DescriptionSandoz is leading company in production of biosimilars, committed to shaping the future of healthcare. With our cutting-edge technology and unwavering dedication, we are revolutionizing the accessibility and affordability of vital biologic medicines. Join us in our mission to make a lasting impact on patients’ lives while driving innovation in field of biosimilars.We are currently seeking Senior Technical Stewards specializing in Upstream, Downstream Bioprocesses, and/or Analytical to join our biomanufacturing site.As a Senior Technical Steward in MS&T, you will be the subject matter expert (SME) in biosimilar manufacturing processes and analytics, focusing on upstream cell culture, downstream antibody purification, and/or analytical technologies. You will play a critical role in ensuring robust process performance, driving innovation, supporting product lifecycle activities, and enabling successful technology transfers and launches.Join a leading biopharmaceutical organization where your expertise will shape the future of biosimilar manufacturing. You will work in a dynamic, innovative environment with global reach, scientific depth, and meaningful impact on patient health.Your Key ResponsibilitiesYour responsibilities include, but are not limited to:Process And Product Technical Leadership & Subject Matter ExpertiseServe as an expert in biosimilar manufacturing processes and analytics, particularly in upstream and/or downstream operations and/or related analytics.Lead and support investigations of complex technical issues related to product, process, technologies, and equipment.Stay abreast of the latest technological advancements in pharmaceutical manufacturing and proactively introduce and implement new technologies to improve efficiency, quality, and compliance.Process Technology & Equipment StewardshipAct as the key point of contact for technologies and equipment in your area of expertise.Collaborate cross-functionally with Technical Development, global MS&T teams, and other manufacturing sites to ensure effective knowledge sharing and technical transfers.Be the recognized scientific expert on site for scientific argumentations and product impact assessments. Act as the SME for assigned technology platforms during process transfers from development or launch to commercial manufacturing.Audit & Compliance SupportProvide scientific insights during internal and external audits and inspections.Collaborate with Product Stewards to support product lifecycle management and ensure continued process verification and regulatory compliance.What You Will Bring To The RoleMinimum 12 years of relevant experience in biomanufacturing, technical development, MS&T, or quality, with a focus on large-scale manufacturing technologies and biosimilars.Proven expertise in upstream cell culture, downstream purification, and/or analytical sciences for monoclonal antibodies and biosimilars.BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemical Engineering, or a related scientific discipline. PhD or equivalent experience is strongly preferred.Demonstrated ability to lead cross-functional investigations and manage complex technical challenges.Strong understanding of regulatory requirements, process validation, continued process verification, and cGMP.Excellent communication and presentation skills, with a proven track record of scientific contribution via publications or conference participation.You’ll ReceiveEmployment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.Possible job locations: Lendava, Slovenia (relocation is possible).We offer permanent contract with a probationary period of 6 months.You are kindly invited to submit your application in the English language, including your CV by October 31, 2025.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Commitment To Diversity & InclusionSandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.#BioRampUp #Sandoz______________________________________________________________________________________________________________________Trenutno iščemo Višjega eksperta procesnih tehnologij s specializacijo za upstream, downstream bioprocesne tehnologije in/ali analitiko, ki bi se pridružili naši biofarmacevtski proizvodni enoti.Kot Višji ekspert procesnih tehnologij v oddelku MS&T boste delovali kot strokovnjak za posamezno področje (SME) na področju proizvodnih procesov in analitike za biosimilarje, s poudarkom na celičnih kulturah (upstream), prečiščevanju protiteles (downstream) in/ali analitičnih tehnologijah. Igrali boste ključno vlogo pri zagotavljanju stabilnega delovanja procesov, spodbujanju inovacij, podpori dejavnostim v celotnem življenjskem ciklu izdelkov ter pri uspešnih prenosih tehnologij in lansiranjih izdelkov.Pridruži se svetovnemu ponudniku trajnostnih generičnih in podobnih bioloških zdravil, kjer bo tvoje strokovno znanje oblikovalo prihodnost proizvodnje biološko podobnih zdravil. Deloval/a boš v dinamičnem in inovativnem okolju z globalnim dosegom, znanstveno globino in pomembnim vplivom na zdravje bolnikov.Vaše Ključne OdgovornostiVaše naloge bodo vključevale, vendar ne bodo omejene na:Tehnično Vodenje Procesov In Izdelkov Ter Strokovno ZnanjeDelovali boste kot strokovnjak/inja za proizvodne procese in analitiko biološko podobnih zdravil, zlasti na področju upstream in/ali downstream operacij ter/ali sorodne analitike.Vodlii in podpirali boste preiskave zapletenih tehničnih težav, povezanih z izdelki, procesi, tehnologijami in opremo.Spremljali najnovejši tehnološki razvoj na področju (bio)farmacevtske proizvodnje ter proaktivno uvajali nove tehnologije z namenom izboljšanja učinkovitosti, kakovosti in skladnosti.Skrbništvo Nad Procesno Tehnologijo In OpremoDelovali boste kot ključna kontaktna oseba za tehnologije in opremo na svojem strokovnem področju.Sodelovali boste s tehničnim razvojem, globalnimi MS&T ekipami in drugimi proizvodnimi lokacijami za učinkovito deljenje znanja in tehnične prenose.Na lokaciji boste delovali kot priznani/a znanstveni/a strokovnjak/inja za znanstvene utemeljitve in ocene vpliva na izdelek. Delovali kot SME (strokovnjak/inja za določeno področje) za dodeljene tehnološke platforme med prenosi procesov iz razvoja ali lansiranja v komercialno proizvodnjo.Podpora Pri Revizijah In SkladnostiNudili boste znanstvene vpoglede med notranjimi in zunanjimi revizijami ter inšpekcijami.Sodelovali boste s skrbniki izdelkov (Product Stewards) pri upravljanju življenjskega cikla izdelkov in zagotavljanju stalne verifikacije procesov ter skladnosti z regulativo.Vaš Doprinos k Delovnemu MestuNajmanj 12 let ustreznih izkušenj v biofarmacevtski proizvodnji, tehničnem razvoju, MS&T ali kakovosti, s poudarkom na tehnologijah za proizvodnjo v velikem merilu (large scale) in biološko podobnih zdravilih.Dokazano strokovno znanje na področju upstream celičnih kultur, downstream čiščenja in/ali analitičnih znanosti za monoklonska protitelesa in biološko podobna zdravila.Diploma iz farmacije, farmacevtske tehnologije, biokemije, kemijskega inženirstva ali sorodne znanstvene smeri. Doktorat (PhD) ali enakovredne izkušnje so močno zaželene.Dokazane sposobnosti vodenja medfunkcijskih preiskav in reševanja kompleksnih tehničnih izzivov.Močno razumevanje regulativnih zahtev, validacije procesov, stalne verifikacije procesov (CPV) in dobre proizvodne prakse (cGMP).Odlične komunikacijske in predstavitvene veščine ter dokazano znanstveno udejstvovanje preko objav ali sodelovanja na konferencah.Kaj NudimoZaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.Možne lokacije dela: Lendava, SlovenijaZ izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.Prijave z življenjepisom v angleškem jeziku lahko oddate najkasneje do 31. oktobra 2025 preko spletne povezave.Zakaj Sandoz in Lek?Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje 20.000 ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več!Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.Prihodnost je v naših rokah!Predani Smo Raznolikosti In VključenostiSandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.#BIORampUp #Sandoz
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